Know Cancer

or
forgot password

A Phase I Study of Monotherapy Dalotuzumab and Ridaforolimus-Dalotuzumab Combination Treatment in Pediatric Patients With Advanced Solid Tumors


Phase 1
3 Years
17 Years
Open (Enrolling)
Both
Solid Tumors

Thank you

Trial Information

A Phase I Study of Monotherapy Dalotuzumab and Ridaforolimus-Dalotuzumab Combination Treatment in Pediatric Patients With Advanced Solid Tumors

Inclusion Criteria


Inclusion criteria:

- Participants of age 3 to 17 years for Part 1 of the study and age 6 to 17 years for
Parts 2 and 3 of the study

- Histologic or cytologic diagnosis of a malignant solid tumor, including tumors of the
central nervous system and lymphoma, that have progressed despite standard therapy or
for which no effective standard therapy is known.

- Measurable or non-measurable disease for Parts 1 and 2; measurable disease for Part 3

- Parts 2 and 3: must be able to swallow tablets

- Performance Status: Lansky Play Scale ≥70 for children <10 years of age; Karnofsky
score ≥70 for children ≥10 to <16 years; or Eastern Cooperative Oncology Group (ECOG)
Status 0-2 for patients age 16 and older

- Adequate organ function

- For females of reproductive potential, a negative pregnancy test must be documented
within 72 hours of receiving the first dose of study medication

- Participants of reproductive potential must agree to use (or have their partner use)
adequate contraception throughout the study, starting with Visit 1 through 30 days
after the last dose of study drug

Exclusion criteria:

- Currently receiving any other investigational agents or using any investigational
devices

- Leukemia

- Previously received dalotuzumab or other IGF-1R inhibitors for Part 1

- History of allergic reactions attributed to compounds of similar chemical or biologic
composition to dalotuzumab or ridaforolimus

- Persistent acute toxicity from previous therapy ≥Grade 2 (excluding alopecia,
neuropathy, or hearing loss)

- Uncontrolled intercurrent illness despite adequate therapy

- Pregnant or breastfeeding

- For Parts 2 and 3: requirement for concurrent treatment with medications that are
inducers or inhibitors of cytochrome P450 (CYP3A)

- Poorly controlled Type 1 or 2 diabetes

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Number of participants with dose limiting toxicities (DLTs) while receiving dalotuzumab alone

Outcome Time Frame:

First 21 days of treatment

Safety Issue:

Yes

Authority:

United States: Food and Drug Administration

Study ID:

8669-062

NCT ID:

NCT01431547

Start Date:

February 2012

Completion Date:

October 2013

Related Keywords:

  • Solid Tumors
  • Neoplasms

Name

Location